TRIATHLON PKR SYSTEM

Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

HOWMEDICA OSTEONICS CORP

The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Triathlon Pkr System.

Pre-market Notification Details

• Device ID: K071881
• 510k Number: K071881
• Device Name: TRIATHLON PKR SYSTEM
• Classification: Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
• Applicant: HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430
• Contact: Vivian Kelly
• Correspondent: Vivian Kelly; HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430
• Product Code: HRY
• CFR Regulation Number: 888.3530 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-07-09
• Decision Date: 2007-10-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327015478	K071881	000
07613327015676	K071881	000
07613327015683	K071881	000
07613327015690	K071881	000
07613327015706	K071881	000
07613327015713	K071881	000
07613327015720	K071881	000
07613327015737	K071881	000
07613327015744	K071881	000
07613327015751	K071881	000
07613327015768	K071881	000
07613327015775	K071881	000
07613327015782	K071881	000
07613327015799	K071881	000
07613327015805	K071881	000
07613327015812	K071881	000
07613327015829	K071881	000
07613327015669	K071881	000
07613327015652	K071881	000
07613327015492	K071881	000
07613327015508	K071881	000
07613327015515	K071881	000
07613327015522	K071881	000
07613327015539	K071881	000
07613327015546	K071881	000
07613327015553	K071881	000
07613327015560	K071881	000
07613327015577	K071881	000
07613327015584	K071881	000
07613327015591	K071881	000
07613327015607	K071881	000
07613327015614	K071881	000
07613327015621	K071881	000
07613327015638	K071881	000
07613327015645	K071881	000
07613327015836	K071881	000
07613327015843	K071881	000
07613327016031	K071881	000
07613327016048	K071881	000
07613327016055	K071881	000
07613327016062	K071881	000
07613327016079	K071881	000
07613327027730	K071881	000
07613327027747	K071881	000
07613327027754	K071881	000
07613327027761	K071881	000
07613327027778	K071881	000
07613327027785	K071881	000
07613327027792	K071881	000
07613327027808	K071881	000
07613327027815	K071881	000
07613327027822	K071881	000
07613327027839	K071881	000
07613327016024	K071881	000
07613327016017	K071881	000
07613327015850	K071881	000
07613327015867	K071881	000
07613327015874	K071881	000
07613327015881	K071881	000
07613327015898	K071881	000
07613327015904	K071881	000
07613327015911	K071881	000
07613327015928	K071881	000
07613327015935	K071881	000
07613327015942	K071881	000
07613327015959	K071881	000
07613327015966	K071881	000
07613327015973	K071881	000
07613327015980	K071881	000
07613327015997	K071881	000
07613327016000	K071881	000
07613327027846	K071881	000